Section 343 - Misbranded food

59 Analyses of this statute by attorneys

  1. Navigating CBD Labeling Litigation Risk Under California and Federal Law

    Quinn Emanuel Urquhart & Sullivan, LLPFebruary 1, 2022

    4; Cal. Code Regs. tit. 4, ยงยง15718-25. 21 U.S.C. ยง 343(q); 21 C.F.R. 101.9(c). 21 U.S.C. ยง343(a). 21 C.F.R. 101.13(i).

  2. Alert: Whatโ€™s at Steak: USDA Solicits Comments on Cultured Meat Labels

    Cooley LLPChris HollyOctober 14, 2021

    NotesSee Federal Food, Drug, and Cosmetic Act (21 U.S.C. ยง 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. ยง 1451, et seq.)See Federal Meat Inspection Act (FMIA; 21 U.S.C. ยง 601 et. seq); Poultry Products Inspection Act (PPIA; 21 U.S.C. ยง 451,et seq.)21 U.S.C. ยงยง 601(n)(1) and 453(h)(1); 21 U.S.C. ยง 343(a).21 U.S.C. ยงยง 601(n)(2) and 453(h)(2); 21 U.S.C. ยง 343(b).

  3. Claims Permitted by Regulations Were Preempted

    Kramer Levin Naftalis & Frankel LLPNovember 6, 2016

    he Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. ยง 501.212(1).The Supremacy Clause of the Constitution provides that the laws of the United States โ€œshall be the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.โ€ U.S. Const. art. VI cl. 2. The Supremacy Clause thus empowers Congress to preempt state laws. Arizona v. United States, 132 S.Ct. 2492, 2500 (2012). Among others, one way in which Congress may preempt state laws is through express preemption. See Shuford v. Fidelity Nat. Property & Cas. Ins. Co., 508 F.3d 1337, 1344 (11th Cir. 2007). Express preemption occurs โ€œwhen Congress has manifested its intent to preempt state law explicitly in the language of the statute.โ€ Id.The FDCA generally prohibits the โ€œadulteration or misbranding of any food . . . in interstate commerce.โ€ 21 U.S.C. ยง 331(b). The FDCA considers a food product misbranded if its labeling is โ€œfalse or misleading in any particular manner.โ€ 21 U.S.C. ยง 343(a). Congress amended the FDCA in 1990 to โ€œcreate uniform national standards regarding the labeling of food.โ€ Bruton v. Gerber Products Co., 961 F. Supp. 2d 1062, 1079 (N.D. Cal. 2013). As part of those amendments, Congress explicitly preempted any state labeling requirements that are not identical to federal labeling requirements. Henry, 2016 WL 1589900 at *6; 21 U.S.C. ยง 341-1(a) (โ€œno State or political subdivision of a State may directly or indirectly establish . . . any requirement for the labeling of food of the type required in [the enumerated sections of the FDCA, including ยง 343(i)(2)] that is not identical to the requirement of such sectionโ€). Interpreting this preemption clause, courts have consistently found that the FDCA preempts state statute- and common-law-based claims to the extent that they would impose liability for conduct expressly permitted by the FDCA. E.g., Henry, 2016 WL 1589900 at *7 (state-law unfair trade practices claim preempted); Turk v. Gen. Mills, Inc., 662

  4. PHOs Banned in the U.S.: Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

    McGuireWoods LLPJames NealeJune 19, 2015

    Labeling Issues The Order does not alter PHO or trans-fat labeling. Two sections of the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. ยงยง 343(q) and (r), directly apply to trans-fat labeling. Section 343(q) enumerates the requirements for the labeling of nutrition information that typically appears in the Nutrition Facts panel. 21 U.S.C. ยง 343(q).

  5. Summary of U.S. Advertising Laws and Regulations for Malt Beverages and Energy Drinks

    Shumaker, Loop & Kendrick, LLPChristian StaplesJanuary 30, 2020

    org/responsibility/advertising-marketing-code/lxii Id.lxiii Id.lxiv 21 C.F.R. ยง 101.9; 21 U.S.C. ยง 343(q).lxv 21 C.F.R. ยง 101.36 ; 21 U.S.C. ยง 343(s).

  6. Bogus Science Leads To Federal Preemption In The Ninth Circuit

    Reed SmithSteven BoranianJuly 18, 2023

    eged a blended version of the product (like the defendantโ€™s product) cannot be labeled โ€œglucosamine sulfate.โ€The plaintiffs were wrong, and the district court and the Ninth Circuit both ruled that federal regulation of dietary supplements preempted their state-law claims. How did the courts get there? The starting point is the federal Food Drug & Cosmetics Act, which expressly preempts any state-law requirement for the labeling of food that is not identical to federal requirements. Id. at 1016. A private plaintiff therefore can bring state-law claims only if the state law imposes requirements that are identical to those contained in the FDCA. Id.That was the plaintiffsโ€™ hook in Hollins. They argued that they were seeking to enforce state-law requirements that were identical to federal requirementsโ€”namely, that a food is misbranded (1) if it is offered for sale under the name of another food or (2) if its label does not bear the FDA-required nutritional information. Id. at 1014 (citing 21 U.S.C. ยงยง 343(b), 343(q)). We understand those rules. Rockfish should not be held out as red snapper, and maple-flavored corn syrup should not be called maple syrup.The problem with the plaintiffsโ€™ glucosamine claims was that FDA regulations clearly allowed the defendant to label its product โ€œglucosamine sulfate.โ€ The FDA has promulgated regulations governing the labeling for dietary supplements; and for many ingredients, the FDA has established specific reference values. However, where the FDA has not established reference values, such dietary ingredients โ€œshall be declared by their common or usual name.โ€ Id. at 1014-15.This next part is really important. An ingredientโ€™s โ€œcommon or usual nameโ€ is determined by specified testing protocols: โ€œOfficial Methods of Analysisโ€ of the AOAC International or, if no AOAC method is available, โ€œby other reliable and appropriate analytical procedures.โ€ Id. at 1015. Finally, alternate testing methods must be validatedโ€”often known as โ€œcompendial test methods.โ€ Id.Why

  7. The FASTER Act: What Companies Need to Know about the New Food Allergy Law

    Farella Braun + Martel LLPKelly MatayoshiJuly 1, 2021

    Manufacturers can satisfy the actโ€™s labeling requirements in one of two ways:1) including a statement โ€œprinted immediately after or adjacent to the list of ingredientsโ€ that includes the word โ€œcontainsโ€ followed by โ€œthe common or usual name of the major food allergen.โ€ [21 U.S.C. ยง 343(w)(1)(A)].2) listing the major food allergen as an ingredient which, with certain exceptions, must be โ€œfollowed in parentheses by the name of the food source from which the major food allergen is derived.โ€

  8. FDA issues draft guidance on voluntary disclosure of sesame when added as flavoring or spice

    Hogan LovellsMartin HahnNovember 12, 2020

    References1 Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry (November 2020) available at https://www.fda.gov/media/143521/download; See also, Voluntary Disclosure of Sesame as Allergen: Draft Guidance for Industry (10 November 2020) (to be published in the Federal Register 12 November 2020) available at https://public-inspection.federalregister.gov/2020-24727.pdf.2 21 U.S.C. ยง 321(qq)(1).3 21 U.S.C. ยง 343(i); 21 CFR 101.4.4 Citizen Petition, Requests that the FDA require sesame based ingredients to be listed by name (sesame) in the ingredient lists of all foods, Docket No. FDA-2014-P-2035, available at https://beta.regulations.gov/docket/FDA-2014-P-2035.5 83 Fed. Reg. 54594 (30 October 2018).6 21 U.S.C. ยง 343 note.

  9. Ninth Circuit finds reasonable consumers donโ€™t confuse almond milk with cowโ€™s milk

    DentonsBety JavidzadJanuary 4, 2019

    The FDCA only requires that foods imitating other foods bear a label with the word โ€œimitationโ€ and โ€œimmediately thereafter, the name of the food imitated.โ€ 21 U.S.C. ยง 343(c); 21 C.F.R. ยง 101.3(e).

  10. The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

    Morrison & Foerster LLP - Class DismissedLuis Gabriel HoyosJune 14, 2017

    Instead, she contends that it does not matter, because โ€œthe law was settled long ago by the relevant statutes and regulations.โ€ The FDAโ€™s 2016 Final Guidance simply clarified FDAโ€™s position that the use of ECJ instead of sugar is false and misleading under 21 U.S.C. ยง343(a)(1) and its accompanying regulations.[1] Therefore, Plaintiff argues that Jelly Bellyโ€™s use of the term ECJ instead of sugar on Sports Beansโ€™ label violates these regulations and ยง343(a)(1).